DEKRA Medical Device Services
★★★★★
2.1
/ 5
•
47 reviews
DEKRA Medical Device Services offers testing and certification for medical devices, consumer electronics, and connected devices. They also provide consulting in process safety and workplace safety.
DEKRA Medical Device Services specializes in the testing and certification of medical devices, consumer electronics, and connected devices. Their expertise extends to comprehensive EV safety training and consulting services in areas such as process safety, workplace safety, and automotive dealership management. They are also a recognized provider of certification for management system standards, including quality (ISO 9001), medical component manufacturers (ISO 13485), business continuity (ISO 22301), aerospace quality (AS9100), and aerospace repair & maintenance (AS9110). DEKRA aims to be a strategic platform connecting OEMs, MSOs, and the collision ecosystem, ensuring safety and compliance across various industries.
About
**Who they are**
DEKRA Medical Device Services is a specialized entity focused on providing comprehensive support for medical device manufacturers navigating regulatory landscapes. They are recognized for their expertise in testing and certification across various product categories.
**Expertise & scope**
* Testing and certification for medical devices, consumer electronics, and connected devices.
* Consulting services in process safety and workplace safety.
* Coverage across the European Union (EU).
* Services available in English and German.
**Reputation / proof points**
* Accredited testing and certification body.
DEKRA Medical Device Services is a specialized entity focused on providing comprehensive support for medical device manufacturers navigating regulatory landscapes. They are recognized for their expertise in testing and certification across various product categories.
**Expertise & scope**
* Testing and certification for medical devices, consumer electronics, and connected devices.
* Consulting services in process safety and workplace safety.
* Coverage across the European Union (EU).
* Services available in English and German.
**Reputation / proof points**
* Accredited testing and certification body.
Additional information
DEKRA Medical Device Services assists clients in ensuring their products meet stringent EU regulatory requirements. Their approach involves thorough testing and certification processes, crucial for market access. They also offer guidance on safety protocols, enhancing overall product and workplace safety. Engagement typically involves detailed assessments and documentation review to align with EU standards.
Key Highlights
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Offers testing and certification for medical devices, consumer electronics, and connected devices.
Source
“DEKRA Medical Device Services offers testing and certification for medical devices, consumer electronics, and connected devices.”
-
Provides consulting in process safety and workplace safety.
Source
“They also provide consulting in process safety and workplace safety.”
-
Coverage extends across the European Union.
Source
“Coverage: EU”
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Services are available in English and German.
Source
“Languages: English, German”
Certifications & Trust Signals
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DEKRA is a globally recognized testing, inspection, and certification company.
Source
“DEKRA Medical Device Services offers testing and certification for medical devices, consumer electronics, and connected devices.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EU compliance
- Companies requiring testing for consumer electronics and connected devices
- Organizations needing process and workplace safety consulting
How engagement typically works
- Consultative approach to regulatory challenges
- Focus on testing and certification rigor
Typical deliverables
- Test reports
- Certificates of conformity
- Safety assessments
- Regulatory guidance
Good to know
- Best when clients have products intended for the EU market.
HQ:
Stuttgart, US
Languages:
English, German
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
Find EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
IE, IT, FR, AT, DE, DK
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
100+
Onboarding time:
2–14 days
Pricing model:
Retainer
Starting from:
EUR 5,000
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices, Certificates
Supports Training Enablement:
Yes
Data Load Support Level:
Guided
Turnaround SLA:
Custom
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
Intake → scope modules → access & roles setup → data readiness checks → upload plan → training/hand-over
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Supports Actor Registration
false
Supports UDI
false
Supports Vigilance
false
Supports Clinical Investigations
false
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